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Tuesday, May 13, 2008

Merck's JANUMET (sitagliptin/metformin HCl) Recommended for Approval in the European Union to Treat Type 2 Diabetes

April 24, 2008 - Merck & Co., Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended two medicines for marketing approval in the European Union (EU)...
... JANUMET helps many patients lower blood sugar levels through the powerful efficacy of sitagliptin, a DPP-4 inhibitor, and metformin, a mainstay of diabetes therapy. For patients uncontrolled on metformin alone, JANUMET provides weight loss comparable to metformin alone, with no increased risk of hypoglycemia, edema, or gastrointestinal (GI) disturbances beyond metformin alone.

The CHMP has recommended JANUMET to be indicated to improve glycemic control in patients with type 2 diabetes inadequately controlled on diet and exercise plus their maximally tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. The CHMP also recommended JANUMET to be indicated in combination with a sulfonylurea as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulfonylurea... Merck's Press Release -